NCT06428279

Brief Summary

Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (\>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 20, 2024

Last Update Submit

May 24, 2024

Conditions

Keywords

Sexual healthQuality of lifeIntegrative oncology

Outcome Measures

Primary Outcomes (1)

  • patients' satisfaction with their sexual lives

    questionnaire

    1 month

Secondary Outcomes (3)

  • identification of the main physiological and psychological difficulties encountered by patients in their sexual lives

    1 month

  • patients perceived emotions

    1 month

  • description of the impact of sex therapy sessions on the sexual health of the participants

    1 month

Interventions

SurveyBEHAVIORAL

survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants will be adults aged 18 years old or older diagnosed with cancer and undergoing non-pharmacological supportive care during or after their standards cancer treatments at Rafael Institute

You may qualify if:

  • cancer patients
  • adults aged \> 18 years old

You may not qualify if:

  • \<18years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute Rafaël

Levallois-Perret, Institut Rafael, 92300, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

April 19, 2024

Primary Completion

May 19, 2024

Study Completion

May 19, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations